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The Europclip®is indicated for use in surgical procedures on vessels or other tubular structures where a metal ligating clip is required. The device is intended to occlude the tubular structure by compression.

The Europclip is a chevron-shaped clip having a heart-shaped cross-section and transverse grooves across the inner surface of the clip. The clips are supplied sterile, available in four sizes and pre-loaded in a disposable cartridge.

This document describes a 510(k) submission for the Europclip®, a ligating clip device. The submission focuses on demonstrating substantial equivalence to predicate devices rather than independent performance studies with detailed acceptance criteria and clinical trials typically used for AI/ML devices.

Therefore, many of the requested details about acceptance criteria, specific study designs (like MRMC or standalone AI studies), ground truth establishment for AI models, and sample sizes for training/test sets are not applicable to this type of medical device submission.

Here's an attempt to address the request based on the provided information, noting where information is not available due to the nature of the submission:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not applicable. This submission relies on demonstrating substantial equivalence to legally marketed predicate devices through a comparison of design, materials, and intended use, rather than a clinical trial with a "test set" of patient data.
• Data Provenance: Not applicable. The "data" primarily consists of technical specifications and comparisons to existing devices, not clinical data from patients.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

• Not applicable. There was no "test set" of data requiring expert ground truth establishment for this device submission.

4. Adjudication Method for the Test Set

• Not applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No, a MRMC comparative effectiveness study was not done. This device is a medical instrument (a ligating clip), not an AI/ML diagnostic or assistive tool for human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

• No, a standalone performance study as would be done for an AI algorithm was not conducted. This device is a physical surgical instrument.

7. The Type of Ground Truth Used

• Not applicable in the context of AI/ML ground truth. The "ground truth" for this submission is effectively the established performance and safety profile of the predicate devices and the direct comparison to their specifications.

8. The Sample Size for the Training Set

• Not applicable. There is no AI/ML training set for this device.

9. How the Ground Truth for the Training Set was Established

• Not applicable.

Summary of the Study (as presented in the 510(k) Summary):

The study described for the Europclip® is a demonstration of substantial equivalence to predicate devices (Nexus Ligating Clips, Miltex Ligating Clips, Titanium Ligation Clip). This is a regulatory pathway for medical devices that are similar in intended use, technological characteristics, and safety/effectiveness to a legally marketed predicate device.

The "study" asserts that:

• The Europclip functions in the same manner as the predicates to occlude blood vessels.
• It possesses the same technological characteristics as one or more predicate devices, including:
  • Identical intended use.
  • Basic design (chevron-shaped with heart-shaped cross-section).
  • Material (titanium).
  • Sizes (dimensions are comparable to those offered by predicate systems).
• The fundamental scientific technology of the Europclip is the same as previously cleared devices.

Based on these comparisons, the sponsor concludes that the Europclip is substantially equivalent to the predicate devices and thus meets the necessary criteria for FDA clearance. The FDA's outcome (K111930) confirms their agreement with this assessment, finding the device substantially equivalent.

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